UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024163 |
|---|---|
| Receipt number | R000027672 |
| Scientific Title | Coagulation effect of sugammadex using thromboelastography in a randomized controlled study of surgical patients |
| Date of disclosure of the study information | 2016/09/26 |
| Last modified on | 2018/02/21 11:40:48 |
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Basic information
Public title
Coagulation effect of sugammadex using
thromboelastography in a randomized controlled study of surgical patients
Acronym
Coagulation effect of sugammadex using
thromboelastography
Scientific Title
Coagulation effect of sugammadex using
thromboelastography in a randomized controlled study of surgical patients
Scientific Title:Acronym
Coagulation effect of sugammadex using
thromboelastography
Region
| Asia(except Japan) |
Condition
Condition
Anticoagulant action of sugammadex
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of
sugammadex, reversing agent of steroidal
neuromuscular blocking agent, on
coagulation competence as measured by
the thromboelastography in perioperative
period after abdominal surgery.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
reaction time (r)
coagulation time (k)
Key secondary outcomes
Maximum rate of thrombus generation (MRTG)
Time to maximum rate of
thrombus generation (TMRTG)
Maximum amplitude (MA)
Angle alpha
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pyridostigmine 0.15 mg/kg plus glycopyrrolated administered atthe end of surgery.
Interventions/Control_2
Sugammadex 4mg/kg, administered at the end of surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
American society of Anesthesiologists physical class 1-2, presenting for elective surgery (gynaecological, urologic, and colorectal surgery) were enrolled.
Key exclusion criteria
Patients were excluded from study if they have neuromuscular disease, hereditary coagulation defect, renal or hepatic dysfunction, known allergy to sugammadex, recent history of hemorrhage or thrombosis within 30 days, difficult airway features, abnormal coagulation laboratory value
(e.g., prothrombin time internalization normalized ratio >1.5, activated partial thromboplastin time > 50 sec), or if they were pregnant or women who were breast feeding.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hae Wone Chang |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
Address
148 Gurodong-ro, Guro-gu, Seoul
TEL
82226263237
chelenh@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mido Lee |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
Address
148 Gurodong-ro, Guro-gu, Seoul
TEL
82226261437
Homepage URL
midoyee@gmail.com
Sponsor or person
Institute
Korea University Guro Hospital
Department of Anesthesiology and Pain
Medicine
Institute
Department
Personal name
Funding Source
Organization
Korea University Guro Hospital
Department of Anesthesiology and Pain
Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Korea University Guro Hospital (Seoul)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 21 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2018 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027672
